ulonivirine (MK-8507) / Merck (MSD) - LARVOL DELTA

A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019) (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (clinicaltrials.gov) - P2/3 | N=570 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 ➔ Dec 2031

Trial completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Switching to Islatravir + Ulonivirine Once Weekly Maintained HIV-1 Viral Suppression at Week 24 in the Presence of Baseline NNRTI Resistance-Associated Mutations and M184I/V in Proviral DNA (IDWeek 2026) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Patient-Reported Outcomes From Virologically Suppressed Adults Living With HIV-1 Switching to Once-Weekly Oral Islatravir in Combination With Ulonivirine: Phase 2b Week 24 Results (IDWeek 2026) - No abstract available

Clinical • Combination therapy • P2b data • Patient reported outcomes • Human Immunodeficiency Virus • Infectious Disease

Randomized, active-controlled, phase 2b study evaluating efficacy and safety of switch to islatravir (ISL) 2 mg with ulonivirine (ULO) 200 mg once weekly in virologically suppressed adults living with HIV-1 (AIDS 2026) - P2 | "BACKGROUND: The ongoing MK-8591B-060 study evaluates the nucleoside reverse-transcriptase translocation inhibitor (NRTTI) ISL combined with the non-nucleoside reverse-transcriptase inhibitor (NNRTI) ULO as oral, once-weekly treatment in virologically suppressed people living with HIV-1. ISL+ULO maintained a high rate of confirmed virologic suppression through W24, with efficacy comparable to BIC/FTC/TAF. ISL+ULO was generally well-tolerated; no safety concerns were identified."

Clinical • Late-breaking abstract • P2b data • Human Immunodeficiency Virus • Infectious Disease • CD4

Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014) (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Sep 2026 ➔ Jun 2027 | Trial completion date: Sep 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Hepatitis C • Hepatology • Liver Failure

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019) (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A clinical study of islatravir and ulonivirine for people with HIV-1 who have not been treated before (MK-8591B-062) (clinicaltrialsregister.eu) - P2/3 | N=35 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) (clinicaltrials.gov) - P1 | N=62 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (clinicaltrials.gov) - P2/3 | N=570 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Oct 2029 ➔ Apr 2029

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of [14C]Ulonivirine ([14C]MK-8507) in Healthy Adults (MK-8507-006) (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) (clinicaltrials.gov) - P1 | N=62 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (clinicaltrials.gov) - P2/3 | N=570 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Human Immunodeficiency Virus • Infectious Disease

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (clinicaltrials.gov) - P2/3 | N=570 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2027 ➔ Sep 2031

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

An Open-Label Phase 1 Study to Evaluate the Effect of Multiple Doses of Rifabutin on the Single-Dose Pharmacokinetics of Ulonivirine in Adults without HIV (IDWeek 2025) - No abstract available

Clinical • P1 data • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

A double-blind, active-controlled, phase 2b study to evaluate the efficacy and safety of ulonivirine in combination with islatravir in virologically suppressed adults living with HIV-1 (IAS-HIV 2025) - P2 | "This double-blind, phase 2b trial evaluated the efficacy and safety of ISL+ULO QW in virologically suppressed adults living with HIV-1 (MK-8591-013; NCT04564547). Participants without known NNRTI resistance who were virologically suppressed for =6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), were randomized (1:1:1:1) to receive ISL 20 mg plus ULO (100, 200, or 400 mg) QW, or remain on BIC/FTC/TAF once-daily. ISL+ULO showed efficacy in maintaining viral suppression through Week 24. Consistent with previous studies of ISL, decreases in TLC and CD4+ counts were observed with ISL 20 mg + ULO QW followed by a trend to recovery after discontinuation. Development of ISL 2 mg + ULO QW is ongoing."

Clinical • Combination therapy • P2b data • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Phase 2 once-weekly dose optimization for ulonivirine in combination with Islatravir 2 mg (IAS-HIV 2025) - P3 | "ULO data from Phase 1 and the previous Phase 2 studies were used to predict a safe and efficacious Phase 2 ULO dose to be combined with ISL 2 mg QW, which is the lower ISL dose used in ongoing clinical trials in combination with oral lenacapavir [NCT06630286; NCT06630299] and is expected to be safe and efficacious. Reduction in viral load (measured as log10 plasma HIV-1 RNA copies/mL]) and ULO pharmacokinetics (PK) from a Phase 1b study where treatment-naïve participants living with HIV-1 received single oral doses of ULO (40, 80, or 600 mg) were used to establish a wild-type (WT) efficacy PK threshold. Dose selection factors weighed PK coverage and virological efficacy. Weekly 200 mg ULO in combination with ISL 2 mg was selected for Phase 2 for continued clinical development."

Combination therapy • P2 data • Human Immunodeficiency Virus • Infectious Disease